CRED Managing Variations Effectively

The withdrawal of the UK from the EU has an impact to medicinal products for the EU market as: - Sites for batch release need to be located in an EU/EEA MS. - Site for batch control for finished product needs to be located in the EU/EEA or a country covered by a mutual recognition agreement. - A site responsible for importation in the EU/EEA needs to be in place for medicinal products manufactured outside the EU/EEA.

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